Postoperative CareNCT03777150
Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients?
A study testing Postoperative care in Intensive care unit (ICU) and Postoperative care in standard ward in people with Postoperative Care and Intensive Care, run by Saint Savvas Anticancer Hospital at 1 site in Greece.
Trial summary
Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been considered to be the gold standard of care in terms of reducing perioperative mortality.New evidence from a 7-day cohort study involving 27 countries comes to question this practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Care, Intensive Care
- What is being tested?
- Postoperative care in Intensive care unit (ICU) and Postoperative care in standard ward
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 10 Oct 2018to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients that will be scheduled for an elective operation and are considered to be in a high perioperative risk
Who cannot join
- Patients that are operated on an emergency basis
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Saint Savvas Anticancer Hospital of Athens
Athens
Georgia Micha, MD, MSc, PhD, +306974828254
About this study
Official title: Is There a Benefit of Postoperative ICU Management After Elective Surgery in Terms of Patient's Outcome, Length of Hospital Stay, Complications and Cost?
Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been considered to be the gold standard of care in terms of reducing perioperative mortality.New evidence from a 7-day cohort study involving 27 countries comes to question this practice. The primary objective of our study is to detect any benefit of postoperative ICU care after elective surgery in terms of patient's outcome, length of hospital stay, complications and cost.
Read the detailed description
A prospective analysis of high perioperative risk patients that are about to be subjected into an elective operation will be included into the study. They will be allocated into two groups. Group ICU patients are those that are admitted into the ICU for postoperative care and those that are admitted into a standard ward consist Group Ward. Demographic data, the length of hospital stay, the outcome, the need of mechanical ventilation, the complications and the total cost will be recorded.
- Conditions
- Postoperative Care, Intensive Care
- Being tested
- Postoperative care in Intensive care unit (ICU), Postoperative care in standard ward
- Keywords
- Intensive care, postoperative care, elective surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative care in Intensive care unit (ICU)Other
Postoperative care in Intensive care unit (ICU)
Postoperative care in standard wardOther
Postoperative care in standard ward
| Study group | Role | What they receive |
|---|---|---|
| Group ICU | Experimental | Group ICU:patients are admitted directly into the ICU for postoperative care Receives: Other: Postoperative care in Intensive care unit (ICU) |
| Group Ward | Experimental | Group Ward:patients are admitted directly into the standard ward for postoperative care Receives: Other: Postoperative care in standard ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total length of hospital stay
The total length of patient's hospital stay will be recorded
Measured: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Secondary outcomes (6)
Preoperative length of hospital stay
The preoperative length of patient's hospital stay will be recorded
Measured: From date of hospital admission until the date of operation or date of death from any cause, whichever came first, assessed up to 6 months
Postoperative length of hospital stay
The postoperative length of patient's hospital stay will be recorded
Measured: From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Postoperative complications
All postoperative complications will be recorded
Measured: From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Patient's outcome at 28 days postoperatively
28 day postoperative mortality will be recorded
Measured: From the first postoperative day until 28 days postoperatively
Total cost of hospital care
The total cost of hospital care will be recorded for every patient
Measured: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Postoperative cost of hospital care
The postoperative cost of hospital care will be recorded for every patient
Measured: From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start10 Oct 2018
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Savvas Anticancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Micha, Saint Savvas Anticancer Hospital
- Investigators
- Anna Efthimiou, Head of the department, Study director, Saint Savvas Anticancer hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777150
- Sponsor's protocol ID
- ICU postoperative care
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Benefit of Postoperative ICU Management After Elective Surgery in Terms of Patient's Outcome, Length of Hospital Stay, Complications and Cost?
- ClinicalTrials.gov ID
- NCT03777150
- Acronym / sponsor ID
- ICU postoperative care
- Conditions
- Postoperative Care, Intensive Care
- Keywords
- Intensive care, postoperative care, elective surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Saint Savvas Anticancer HospitalUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been considered to be the gold standard of care in terms of reducing perioperative mortality.New evidence from a 7-day cohort study involving 27 countries comes to question this practice. The primary objective of our study is to detect any benefit of postoperative ICU care after elective surgery in terms of patient's outcome, length of hospital stay, complications and cost.
Detailed description
A prospective analysis of high perioperative risk patients that are about to be subjected into an elective operation will be included into the study. They will be allocated into two groups. Group ICU patients are those that are admitted into the ICU for postoperative care and those that are admitted into a standard ward consist Group Ward. Demographic data, the length of hospital stay, the outcome, the need of mechanical ventilation, the complications and the total cost will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care
| Arm | Type | Receives |
|---|---|---|
| Group ICU | Experimental | Other: Postoperative care in Intensive care unit (ICU)Group ICU:patients are admitted directly into the ICU for postoperative care |
| Group Ward | Experimental | Other: Postoperative care in standard wardGroup Ward:patients are admitted directly into the standard ward for postoperative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients that will be scheduled for an elective operation and are considered to be in a high perioperative risk
Key exclusion criteria (1 listed)
- Patients that are operated on an emergency basis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative care in Intensive care unit (ICU)Postoperative care in Intensive care unit (ICU) | Other | Group ICU |
| Postoperative care in standard wardPostoperative care in standard ward | Other | Group Ward |
Primary outcome
Total length of hospital stay
Time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
The total length of patient's hospital stay will be recorded
6 secondary outcomes
Preoperative length of hospital stay
Time frame: From date of hospital admission until the date of operation or date of death from any cause, whichever came first, assessed up to 6 months
Postoperative length of hospital stay
Time frame: From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Postoperative complications
Time frame: From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Patient's outcome at 28 days postoperatively
Time frame: From the first postoperative day until 28 days postoperatively
Total cost of hospital care
Time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Postoperative cost of hospital care
Time frame: From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Care
Not yet recruitingPhase 4
Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
Heart Failure, Cardiac Surgery
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Efthimiou, Head of the department study director
Saint Savvas Anticancer hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative care in Intensive care unit (ICU) and Postoperative care in standard ward in people with Postoperative Care and Intensive Care, run by Saint Savvas Anticancer Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgia Micha, MD, PhD (6974828254 ext. 0030, mgeo3@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total length of hospital stay (time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.